Radiation Dermatitis
Conditions
Brief summary
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
Detailed description
This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy. Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy. Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.
Interventions
DEVICETHOR Laser System for Low Level Laser Therapy (LLLT)
Non-invasive, a cold laser output treatment.
Sponsors
Heath Skinner
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients ≥ 18 years of age * Karnofsky performance status \> 70 * Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * No prior radiotherapy to the head and neck region. * No previous systemic chemotherapy or targeted therapy * Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts. * Patients using standard therapies for cetuximab-induced acne-form rash will be included.
Exclusion criteria
* Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies * Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator * Concurrent serious infection * Continued use of Niacin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3 or Higher Adverse Events | Up to 12 months | Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| University of Washington Quality of Life Questionnaire (UW-QOL) | At Baseline | The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score. |
| Brief Pain Inventory (BPI) | Baseline | Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item. |
| Dermatology Life Quality Index (DLQI) | Baseline | Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Level Laser Therapy Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Low Level Laser Therapy |
|---|---|
| Age, Continuous | 69.62 years STANDARD_DEVIATION 12.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 16 |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 9 / 16 |
Outcome results
Primary
Grade 3 or Higher Adverse Events
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
Time frame: Up to 12 months
Population: Patients who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Level Laser Therapy | Grade 3 or Higher Adverse Events | 9 Participants |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: 7.5-10.5 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 3 score on a scale | Standard Deviation 2.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 5.2 score on a scale | Standard Deviation 1.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 2.6 score on a scale | Standard Deviation 2.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 2.5 score on a scale | Standard Deviation 2.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 0.8 score on a scale | Standard Deviation 1.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 5.1 score on a scale | Standard Deviation 3 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 3.5 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 3.8 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 3.1 score on a scale | Standard Deviation 2.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 3.9 score on a scale | Standard Deviation 3.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 4.8 score on a scale | Standard Deviation 2.4 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: Baseline
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 6.3 score on a scale | Standard Deviation 2.6 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 5.8 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 5.0 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 5.6 score on a scale | Standard Deviation 3.3 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 4.3 score on a scale | Standard Deviation 3.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 6.3 score on a scale | Standard Deviation 2.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 3.0 score on a scale | Standard Deviation 3.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 5.5 score on a scale | Standard Deviation 2.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 4.0 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 4.8 score on a scale | Standard Deviation 2.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 7.1 score on a scale | Standard Deviation 2.2 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: Up to 4.5 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 5.5 score on a scale | Standard Deviation 2.6 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 5.1 score on a scale | Standard Deviation 3.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 5.2 score on a scale | Standard Deviation 3.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 3.7 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 3.6 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 5.9 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 3.3 score on a scale | Standard Deviation 3.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 5 score on a scale | Standard Deviation 2.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 4.1 score on a scale | Standard Deviation 2.3 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 5.4 score on a scale | Standard Deviation 3.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 6.3 score on a scale | Standard Deviation 3.3 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: 4.5-7.5 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 2.7 score on a scale | Standard Deviation 3.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 4.0 score on a scale | Standard Deviation 4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 4.3 score on a scale | Standard Deviation 4.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 4.3 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 3.7 score on a scale | Standard Deviation 3.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 4.3 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 4.3 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 5.8 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week (N | 3.5 score on a scale | Standard Deviation 3.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 4.8 score on a scale | Standard Deviation 2.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 4.3 score on a scale | Standard Deviation 3.3 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: 10.5-13.5 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 0.5 score on a scale | Standard Deviation 0.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 1.5 score on a scale | Standard Deviation 2.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 0.5 score on a scale | Standard Deviation 0.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 0.5 score on a scale | Standard Deviation 0.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 0.0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 3.0 score on a scale | Standard Deviation 4.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 0.5 score on a scale | Standard Deviation 0.7 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 3.5 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 3.0 score on a scale | Standard Deviation 4.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 3.0 score on a scale | Standard Deviation 4.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 4.0 score on a scale | Standard Deviation 2.8 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: 13.5-16.5 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 6.5 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 6.5 score on a scale | Standard Deviation 4.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 6.5 score on a scale | Standard Deviation 3.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 7.0 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 4.5 score on a scale | Standard Deviation 4.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 6.5 score on a scale | Standard Deviation 4.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 4.5 score on a scale | Standard Deviation 6.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 4.5 score on a scale | Standard Deviation 4.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 5.0 score on a scale | Standard Deviation 4.2 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 5.0 score on a scale | Standard Deviation 7.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 5.5 score on a scale | Standard Deviation 6.4 |
Secondary
Brief Pain Inventory (BPI)
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but worst pain or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Time frame: after 16.5 months, up to 48.9 months
Population: Treated patients who completed BPI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | General Activity | 2.2 score on a scale | Standard Deviation 2.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Enjoyment of Life | 2 score on a scale | Standard Deviation 2.4 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Mood | 1.8 score on a scale | Standard Deviation 2.6 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Normal Work | 2.4 score on a scale | Standard Deviation 2.9 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Relationships | 1.2 score on a scale | Standard Deviation 1.5 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Sleep | 1.7 score on a scale | Standard Deviation 2.8 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Walking Ability | 2.5 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Average pain | 2 score on a scale | Standard Deviation 2.6 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain least in last week | 1.5 score on a scale | Standard Deviation 2.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain right now | 1.7 score on a scale | Standard Deviation 3.1 |
| Low Level Laser Therapy | Brief Pain Inventory (BPI) | Pain Worst in last week | 2.4 score on a scale | Standard Deviation 3 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: Up to 4.5 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 3.3 score on a scale | Standard Deviation 1.2 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 3.2 score on a scale | Standard Deviation 0.9 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 3.2 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 3.4 score on a scale | Standard Deviation 0.7 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 2.6 score on a scale | Standard Deviation 0.9 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 3.7 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.0 score on a scale | Standard Deviation 0.9 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 3.3 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.2 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 0.6 score on a scale | Standard Deviation 0.9 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.7 score on a scale | Standard Deviation 0.3 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: 4.5 - 7.5 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 3.5 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.0 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.5 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 4.5 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.0 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.2 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 0.8 score on a scale | Standard Deviation 1.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.8 score on a scale | Standard Deviation 0.5 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: 7.5-10.5 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 3.9 score on a scale | Standard Deviation 0.4 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.1 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.3 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 3.9 score on a scale | Standard Deviation 0.9 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 3.9 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 3.5 score on a scale | Standard Deviation 1.3 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 2.4 score on a scale | Standard Deviation 1.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 1.9 score on a scale | Standard Deviation 0.4 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: 10.5-13.5 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 4.0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 4.0 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.0 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.5 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.4 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 1.9 score on a scale | Standard Deviation 1.4 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.4 score on a scale | Standard Deviation 0.5 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: 13.5-16.5 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 4.0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 4.0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 4.0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.5 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 4.2 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.0 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 2.2 score on a scale | Standard Deviation 1.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.2 score on a scale | Standard Deviation 0.5 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: after 16.5 months, up to 48.9 months
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 3.8 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 4 score on a scale | Standard Deviation 0.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 4 score on a scale | Standard Deviation 0.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.3 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.5 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 4 score on a scale | Standard Deviation 0.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.3 score on a scale | Standard Deviation 0.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 4 score on a scale | Standard Deviation 0.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.1 score on a scale | Standard Deviation 0.1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 2.2 score on a scale | Standard Deviation 1.4 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.3 score on a scale | Standard Deviation 0.5 |
Secondary
Dermatology Life Quality Index (DLQI)
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Time frame: Baseline
Population: Treated patients who completed DLQI assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Activity | 4.1 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Appearance | 3.7 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Clothes | 4.1 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Messy | 4.3 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Pain | 3.3 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Problems | 4.2 score on a scale | Standard Deviation 0.6 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sexual | 4.1 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Social | 4.1 score on a scale | Standard Deviation 0.8 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Sport | 4.1 score on a scale | Standard Deviation 1 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Studying | 1.3 score on a scale | Standard Deviation 1.5 |
| Low Level Laser Therapy | Dermatology Life Quality Index (DLQI) | Working | 2.5 score on a scale | Standard Deviation 0.5 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: after 16.5 months, up to 48.9 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 35.4 score on a scale | Standard Deviation 12.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 21 score on a scale | Standard Deviation 31.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 11.6 score on a scale | Standard Deviation 13.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 16.7 score on a scale | Standard Deviation 23.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 25.6 score on a scale | Standard Deviation 29.2 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 17.6 score on a scale | Standard Deviation 32.8 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 40.8 score on a scale | Standard Deviation 16.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 15 score on a scale | Standard Deviation 17.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 14 score on a scale | Standard Deviation 16.8 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 2.5 score on a scale | Standard Deviation 5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 33.9 score on a scale | Standard Deviation 45.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 19. score on a scale | Standard Deviation 9.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 46.8 score on a scale | Standard Deviation 10.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 38.8 score on a scale | Standard Deviation 27.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 40.4 score on a scale | Standard Deviation 13.8 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: Up to 4.5 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 54.4 score on a scale | Standard Deviation 12.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 44.1 score on a scale | Standard Deviation 29.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 35 score on a scale | Standard Deviation 19.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 44.4 score on a scale | Standard Deviation 34.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 44.7 score on a scale | Standard Deviation 28.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 49.4 score on a scale | Standard Deviation 26.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 49.4 score on a scale | Standard Deviation 20 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 51.8 score on a scale | Standard Deviation 25.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 20.3 score on a scale | Standard Deviation 29.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 27.3 score on a scale | Standard Deviation 29.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 41.6 score on a scale | Standard Deviation 29.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 79.8 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 55.3 score on a scale | Standard Deviation 18.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 51.4 score on a scale | Standard Deviation 19.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 50.7 score on a scale | Standard Deviation 21.7 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: 4.5-7.5 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 43.8 score on a scale | Standard Deviation 17.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 47.1 score on a scale | Standard Deviation 21.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 25.0 score on a scale | Standard Deviation 18.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 32.1 score on a scale | Standard Deviation 31.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 35.7 score on a scale | Standard Deviation 24.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 34.4 score on a scale | Standard Deviation 26.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 39.3 score on a scale | Standard Deviation 19.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 48.6 score on a scale | Standard Deviation 28.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 30.7 score on a scale | Standard Deviation 29.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 8.6 score on a scale | Standard Deviation 14.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 31.4 score on a scale | Standard Deviation 33.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 52.9 score on a scale | Standard Deviation 21.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 51.4 score on a scale | Standard Deviation 10.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 28.6 score on a scale | Standard Deviation 26.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 42.9 score on a scale | Standard Deviation 13.8 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: At Baseline
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 43.8 score on a scale | Standard Deviation 21.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 47.3 score on a scale | Standard Deviation 32 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 28.1 score on a scale | Standard Deviation 25.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 40.6 score on a scale | Standard Deviation 27.2 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 35.9 score on a scale | Standard Deviation 30.2 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 48.4 score on a scale | Standard Deviation 34.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 35.9 score on a scale | Standard Deviation 22.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 21.3 score on a scale | Standard Deviation 24.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 21.2 score on a scale | Standard Deviation 30.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 15.0 score on a scale | Standard Deviation 15.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 30.0 score on a scale | Standard Deviation 29 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 27.5 score on a scale | Standard Deviation 35.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 42.9 score on a scale | Standard Deviation 20.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 31.7 score on a scale | Standard Deviation 30.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Overall QOL | 37.1 score on a scale | Standard Deviation 17.3 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: 7.5-10.5 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 46.4 score on a scale | Standard Deviation 22.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 37.9 score on a scale | Standard Deviation 24.8 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 21.4 score on a scale | Standard Deviation 18.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 25 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 50 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 30.4 score on a scale | Standard Deviation 26.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 41.1 score on a scale | Standard Deviation 23.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 28.6 score on a scale | Standard Deviation 31.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 14.3 score on a scale | Standard Deviation 27 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 18.6 score on a scale | Standard Deviation 26.7 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 15.7 score on a scale | Standard Deviation 15.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 49.3 score on a scale | Standard Deviation 28.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 46.7 score on a scale | Standard Deviation 15.1 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 16.7 score on a scale | Standard Deviation 21.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 45.0 score on a scale | Standard Deviation 15.2 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: 10.5-13.5 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 37.5 score on a scale | Standard Deviation 14.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 17.5 score on a scale | Standard Deviation 35 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 12.5 score on a scale | Standard Deviation 14.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 12.5 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 18.8 score on a scale | Standard Deviation 12.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 28.1 score on a scale | Standard Deviation 32.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 43.8 score on a scale | Standard Deviation 12.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 25.0 score on a scale | Standard Deviation 33.2 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 30 score on a scale | Standard Deviation 35.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 3.8 score on a scale | Standard Deviation 7.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 15 score on a scale | Standard Deviation 17.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 27.5 score on a scale | Standard Deviation 20.6 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 42.5 score on a scale | Standard Deviation 5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 21.9 score on a scale | Standard Deviation 21.3 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 30 score on a scale | Standard Deviation 11.5 |
Secondary
University of Washington Quality of Life Questionnaire (UW-QOL)
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Time frame: 13.5-16.5 months
Population: Treated patients who completed UW-QOL assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Activity | 46.9 score on a scale | Standard Deviation 29.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Anxiety | 12.5 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Appearance | 6.2 score on a scale | Standard Deviation 12.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Chewing | 12.5 score on a scale | Standard Deviation 25 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Mood | 18.8 score on a scale | Standard Deviation 23.9 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Pain | 0 score on a scale | Standard Deviation 0 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Recreation | 43.8 score on a scale | Standard Deviation 31.5 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Saliva | 7.5 score on a scale | Standard Deviation 15 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Shoulder | 17.5 score on a scale | Standard Deviation 35 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Speech | 7.5 score on a scale | Standard Deviation 15 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Swallowing | 25.0 score on a scale | Standard Deviation 33.2 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Taste | 22.5 score on a scale | Standard Deviation 15 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL last 7 days | 45 score on a scale | Standard Deviation 10 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - QOL since 1 mo. before cancer | 50 score on a scale | Standard Deviation 20.4 |
| Low Level Laser Therapy | University of Washington Quality of Life Questionnaire (UW-QOL) | Global severity - Overall QOL | 35 score on a scale | Standard Deviation 19.1 |